Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

Phase 2

• Conditions: Venezuelan Equine Encephalomyelitis
• Interventions: Biological: VEE TC-83

• Registration Number: NCT00582504
• Lead Sponsor: U.S. Army Medical Research and Development Command

Brief Summary

This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2007-12-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• At least 18 years old
• VEE PRNT80 < 1:10 before immunization.
• (females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
• Actively enrolled in the SIP
• At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
• Up-to-date (within 1 year) physical examination/tests.
• Sign and date the approved informed consent.
• Willing to return for all follow-up visits.
• Agree to report adverse event (AE) up to 28 days after vaccination.

Exclusion Criteria

• Over age of 65 years.
• Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
• History of immunodeficiency or current treatment with immunosuppressive medication.
• (females) Currently breastfeeding.
• Confirmed human immunodeficiency virus (HIV) titer.
• Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (> 125 mg/dL).
• Serious allergic reaction to guinea pigs/guinea pig products.
• Any known allergies to components of the vaccine.
• A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
• Administration of any vaccine within 28 days of TC-83.
• Any unresolved AEs resulting from a previous immunization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccination	VEE TC-83	VEE TC-83

Primary Outcome Measures

Name	Time	Method
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)	21-35 days, 42-56 days, 12-15 months
Number of adverse events.	7 years

Secondary Outcome Measures

Name	Time	Method
Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.	7 years

Trial Locations

Locations (1)

U.S. Army Medical Research Institute of Infectious Diseases; 🇺🇸 Fort Deterick, Maryland, United States